FDA releases annual ‘Generic Drug Roundup’

SILVER SPRING, MD — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

One of the most important was enoxaparin sodium injection, approved in July. The drug, a generic version of Sanofi-Aventis’ anti-clotting drug, Lovenox, is marketed by Sandoz, the generics arm of Swiss drug maker Novartis. While the FDA approved Lovenox as a pharmaceutical, its chemical complexity and production process place it in league with biologics, and many analysts said the special circumstances under which the agency approved it could influence regulations governing biosimilars in the future. Lovenox had sales of $2.7 billion in 2009, according to Sanofi-Aventis financial data.

June saw the approval of Roxane Labs’ anastrozole tablets, a generic version of AstraZeneca’s breast cancer treatment Arimidex, which had sales of $916.8 million, according to IMS Health. Roxane, based in Columbus, Ohio, is the generics arm of German drug maker Boehringer Ingelheim.

Also in June, the FDA approved Teva’s venlafaxine hydrochloride extended-release capsules, a generic version of Wyeth’s major depressive disorder treatment Effexor XR, which has annual sales of around $2.75 billion, according to IMS.

In October, the FDA approved Actavis’ losartan potassium tablets, a generic version of Merck’s Cozaar, used to treat hypertension. Losartan potassium tablets had sales of around $940 million for the 12-month period ended in June, according to IMS.

In July, the agency approved APP Pharmaceuticals’ injected drug aztreonam, a generic version of Bristol-Myers Squibb’s antibiotic Azactam, which had sales of around $86 million in 2009, according to IMS.